Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma.

In the present study, we evaluated the efficacy and safety of rituximab In combi-nation with standard doxorubicin, bleomy-cin, vinblastine, and dacarbazine (RABVD) in patients with classical Hodgkin lym-phoma (cHL). In this phase 2 study, patients with chemotherapy-naive, advanced-stage cHL were treated with rituximab 375 mg/m2 weekly for 6 weeks and standard ABVD for 6 cycles. The primary outcome was event-free survival (EFS) at 5 years. Eighty-five patients were enrolled, of whom 78 were eligible. With a median follow-up duration of 68 months (range, 26-110), and based on an intent-to-treat analysis, the 5-year EFS and overall survival rates were 83% and 96%, respec-tively. The 5-year EFS for patients with stage lll/IV cHLwas 82%. Furthermore, the 5-year EFS for patients with an Interna-tional Prognostic Score of 0-2 was 88% and for those with a score of > 2, it was 73%. The most frequent treatment-related grade 3 or 4 adverse events were neutro-penia (23%), fatigue (9%), and nausea (8%). Our results demonstrate that the addition of rituximab to ABVD is safe and has a promising clinical activity in pa-tients with advanced-stage cHL. These data are currently being confirmed in a multi-center randomized trial. This trial has been completed and is registered with www.clini-caltrials.gov as NCT00504504. {Blood. 2012; 119(18):4123-4128) [ABSTRACT FROM AUTHOR]